• At the ARVO meeting in Seattle, Johnson & Johnson is debuting its EYE-RD Global Registry, an observational, non-interventional global inherited retinal disease (IRD) registry created to make clinical information on IRDs more accessible to patients, providers, payers and researchers. The registry will serve as a centralized repository of longitudinal data collected on genetically tested patients who are diagnosed or have a suspected diagnosis of IRDs such as X-linked retinitis pigmentosa. The registry has the potential to bridge the knowledge gap in IRDs through the collection of real-world data by collating more holistic insights about disease progression and patient experiences, the company says.

• RetiSpec Inc. and Topcon Healthcare announced that Topcon invested in RetiSpec and the two companies are collaborating to bring the RetiSpec technology to market. RetiSpec's eye diagnostic AI aims to help health-care providers predict amyloid burden, a core biomarker of Alzheimer's disease, even before symptoms emerge. The test is available for Research Use Only; however, once commercialized and integrated with Topcon Harmony’s cloud-based clinical data management platform, it will enable early detection of Alzheimer's disease and facilitate timely access to care. According to the companies, the collaboration will accelerate the commercialization and scale of RetiSpec's first brain health indication in Alzheimer's disease. It will also help expedite development of additional AI-powered diagnostic solutions from the eye for early detection and monitoring of neurodegenerative diseases and side effects of the new therapies for Alzheimer's disease. 

• Lupin Limited received approval from the FDA for its abbreviated new drug application for travoprost ophthalmic solution USP, 0.004% (ionic buffered solution), to market a generic equivalent to the reference listed drug Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc. Travoprost ophthalmic solution USP, 0.004%, is indicated for the reduction of elevated IOP in patients with open angle glaucoma or ocular hypertension. The product will be manufactured at Lupin’s Pithampur facility in India.

• EyePoint Pharmaceuticals announced topline results of its Phase 2 PAVIA clinical trial evaluating DURAVYU (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR). While the data demonstrated that DURAVYU has a biologic effect in patients with NPDR with a favorable safety and tolerability profile, it did not meet the pre-specified primary endpoint, which was improvement of at least two DRSS levels as of week 36 after the DURAVYU injection. The company says it plans to provide an update on the path forward for DURAVYU as a potential treatment in NPDR following a review of the full 12-month data. 

• The FDA accepted Eluminex Biosciences’ investigational new drug application for EB-105, a novel trispecific fusion antibody targeting VEGF-A (and isomers), VEGF-B, placental growth factor, angiopoetin-2 and interleukin-6 receptor for the treatment of diabetic macular edema (DME). Details of EB-105 mechanism of action and preclinical science is being presented at three events, including the OIS Meeting in Seattle at the ARVO Meeting on May 9. 

• Inflammasome Therapeutics dosed its first patient in a Phase 1 first-in-class clinical trial for dry AMD (ClinicalTrials.gov ID NCT06164587). The open label 26-week study is designed to evaluate the safety and treatment efficacy of Kamuvudine-8 (K8), a novel neuroprotectant that will target the underlying cause of vision loss in geographic atrophy (GA). The trial is expected to treat up to five subjects with GA due to AMD with intravitreous injection of intraocular implant designed to last for 3 months. Trial participants will receive a tiny, sustained release implant that will provide slow, consistent release of K8, directly into the back of the eye. The combined drug and delivery strategy allows high therapeutic doses to be maintained in the eye while the drug is undetectable in systemic circulation, the company says. 

• A recent study published in the New England Journal of Medicine, showed that CRISPR-Cas9 gene editing was found to be safe and largely effective in addressing a form of inherited blindness in a group of patients that, for the first time, included children. In a multi-site clinical trial called BRILLIANCE that included researchers from the Perelman School of Medicine at the University of Pennsylvania and Children’s Hospital of Philadelphia, 14 people — including two children under 17 years old — with Leber congenital amaurosis, received a single, surgical injection of a gene editing agent. Of those 14, nearly half reported measurable improvements in sight, including the two children. In the end, 11 patients experienced improvement in at least one measure, while six showed improvement in two or more. Meaningful improvements were seen in six patients in cone-mediated vision.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.